Kelly Knupp, MD, Associate Professor of Pediatrics and Neurology at the University of Colorado, discusses supplemental data on the efficacy of fenfluramine in treating Dravet syndrome-associated seizures.
Dravet syndrome is the most severe of a group of conditions known as SCN1A-related seizure disorders. Symptoms include seizures which first occur in infancy that are often triggered by high temperatures. In childhood, many types of seizures may occur and they may increase in frequency. Seizures may be difficult to treat. Other symptoms include loss of motor skills, intellectual disability, speech impairment, and difficulty with movement. Most cases of Dravet syndrome occur when the SCN1A gene is not working correctly.
Fintepla (fenfluramine) is a dual-action sigma-1 receptor and serotonergic activity. It has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients ages 2 years and older.
A review was conducted utilizing data from five literature databases for studies in which treatment with fenfluramine caused changes in generalized tonic-clonic seizures (GTCS) or tonic-clonic seizures (TCS). 14 studies observed 421 patients with various developmental and epileptic encephalopathies, including Dravet syndrome (9 studies).
From the analysis, it was observed that 72 percent of patients from 10 studies (144 patients) treated with fenfluramine achieved a 50 percent or greater reduction in GTCS or TCS from baseline. In nine studies, with a total of 112 patients, 54 percent achieved 75 percent reduction from baseline and 29 percent achieved a 100 percent reduction. This is supplemental to data observed in the fenfluramine clinical trials.
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